Randstad US Jobs

qms engineer.

• austell , georgia

• posted june 18, 2024

job details

summary

• $80,000 - $95,000 per year

• permanent

• bachelor degree

• category computer and mathematical occupations

• reference1055760

job details

job summary:

We are seeking a detail-oriented and proactive Quality Management Systems (QMS) Engineer to oversee and enhance our quality management systems. The ideal candidate will have a deep understanding of quality assurance principles and the ability to implement and maintain QMS to meet industry standards and regulatory requirements.

Education and/or Experience:

· Bachelor's Degree in a science, engineering, or related discipline (Preferred: Chemical, Polymer, Biomedical, Materials Science, Industrial, Mechanical)

· 5+ years of progressively increasing responsibility in a medical device or related industry/organization

· Certified Quality Engineer and/or Certified Reliability Engineer, preferred

· Lean Six Sigma Green Belt or Black Belt, preferred

· Terminal sterilization of medical devices knowledge (EO/Gamma/I-Beam), including validation processes, preferred

Skills and Knowledge Requirements:

· Excellent working knowledge of 21 CFR 820, EU MDR, ISO 13485, and ISO 9001

· strong analytical, problem solving and technical writing skill

· The ability to work with a variety of disciplines and levels of staff both internally and externally

· Ability to work independently or as an integral part of a cross-functional team

· Able to understand, interpret, explain, and resolve technical issues

· strong project management and organizational skills

· Experience with statistical analysis and associated software

location: Austell, Georgia

job type: Permanent

salary: $80,000 - 95,000 per year

work hours: 8am to 4pm

education: Bachelors

responsibilities:

QMS Development: Develop, implement, and maintain Quality Management Systems (QMS) in accordance with ISO standards and regulatory requirements to ensure consistent quality and compliance.

· Ensure implementation and rigor of product development processes and design control procedures are in compliance with the QMS.

· Provide support for post-market surveillance activities including but not limited to complaint investigations, Operations change control/ risk assessments, document control, Quality Systems improvements, Regulatory & certification audit readiness, and internal audits,

· Problem-solving of technical issues related to design, development, and manufacturing supporting compliant, nonconformance, CAPA and SCAR investigations.

· Responsible for coordinating and managing project activities across all cross-functional team members to ensure timely completion of milestones.

· Serve as Audit Quality Administrator and subject matter expert during internal and external audits/inspections.

· Generate, review, approve, and/or execute changes and/or validations for Quality Systems to ensure compliance to US and International requirements for Quality Systems activities.

· Ensuring that the external manufacturers are qualified and monitored in compliance with the Supplier Quality Management program which may include validation/verification review, leading supplier quality audits, developing quality agreements, participating in monitoring activities, issuing SCARS, etc.

· Support complaint investigation activities within cross-functional teams and lead appropriate analysis of the information that supports continuous improvement in a timely manner. Ensure corrective and preventative actions are effective.

· Lead and ensure compliance on Risk Management files which include Design FMEA & Process FMEA.

· Experience in interpreting US and international regulatory requirements and successful submissions for medical devices (510k's, CE mark technical files, etc.).

· In-depth knowledge of applicable global regulatory compliance requirements for personal protective equipment (PPE), drugs, cosmetics, and medical devices, including US FDA, NIOSH, Health Canada, TGA, and EUMDR.

· Knowledge and experience with ISO 13485 and ISO 9001 requirements is required.

#LI-CB6

qualifications:

• Experience level: Experienced

• Minimum 5 years of experience

• Education: Bachelors

skills:

• Quality Systems

• Medical Device

• Regulatory Affairs / Compliance

• Compliance

• QMS

• CAPA

• ISO 13485

• 21 CFR 820

• EU MDR

• Supply Chain

• ISO 9001Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).Applications accepted on ongoing basis until filled.